Clearance Summary
Hair Growth Laser Cap received FDA 510(k) clearance under submission number K252325, sponsored by Cosmo Far East Technology Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-10-22.
- Submission: K252325
- Applicant / Sponsor: Cosmo Far East Technology Limited
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2025-10-22
Classification & Regulation
This clearance is catalogued under FDA product code OAP and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.